14r Winco Foods 67091 385 Bisacodyl Usp 5mg 25 Count

14r Winco Foods 67091 385 Bisacodyl Usp 5mg 25 Count
SPL v2
SPL
SPL Set ID c34db60b-bbea-770f-e053-2a95a90a36da
Route
ORAL
Published
Effective Date 2022-01-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Deacetylbisacodyl (5 mg)
Inactive Ingredients
Carnauba Wax Gelatin Sucrose Ferrosoferric Oxide Magnesium Stearate Shellac Acacia Fd&c Yellow No. 6 Ferric Oxide Yellow Talc Titanium Dioxide Polyethylene Glycol 400 Cellulose, Microcrystalline Polyvinyl Acetate Phthalate Anhydrous Lactose Povidone Sodium Starch Glycolate Type A Corn Stearic Acid Silicon Dioxide Starch, Corn D&c Yellow No. 10 Aluminum Lake Calcium Sulfate Anhydrous

Identifiers & Packaging

Pill Appearance
Imprint: TCL003 Shape: round Color: orange Size: 5 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2022-01-12

Description

Active ingredient (in each tablet) Bisacodyl 5 mg


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

• relieves occasional constipation and irregularity

• this product generally produces bowel movement in 6 to 12 hours

Dosage and Administration

Directions

  • take with a glass of water
adults and children 12 years and over take 1 to 3 tablets in a single daily dose
children 6 to under 12 years of age take 1 tablet in a single daily dose
children under 6 years of age ask a doctor

Description

Active ingredient (in each tablet) Bisacodyl 5 mg

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if

• you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.

• you need to use a laxative for more than 1 week

Section 50567-7

When using this product

• do not chew or crush tablet(s)

• do not use within 1 hour after taking an antacid or milk

• you may have stomach discomfort, faintness or cramps



Section 50569-3

Ask a doctor before use if you have

• stomach pain, nausea or vomiting

• a sudden change in bowel habits that lasts more than 2 weeks

Section 50570-1

Do not use if you cannot swallow without chewing

Section 51727-6

Inactive ingredients acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, gelatin, iron oxide, iron oxide black, iron oxide yellow (iron oxide ochre), magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide

Section 51945-4

Section 53413-1

Comments & Questions? 800-824-1706

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose

Stimulant laxative

Section 55106-9

Active ingredient (in each tablet)

Bisacodyl 5 mg

Section 60561-8

Other Information

each tablet contains: magnesium 5 mg

• store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)

• use by expiration date on package

• protect from excessive humidity




Structured Label Content

Indications and Usage (34067-9)

Uses

• relieves occasional constipation and irregularity

• this product generally produces bowel movement in 6 to 12 hours

Dosage and Administration (34068-7)

Directions

  • take with a glass of water
adults and children 12 years and over take 1 to 3 tablets in a single daily dose
children 6 to under 12 years of age take 1 tablet in a single daily dose
children under 6 years of age ask a doctor

Warnings and Precautions (34071-1)

Warnings

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

• you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.

• you need to use a laxative for more than 1 week

Section 50567-7 (50567-7)

When using this product

• do not chew or crush tablet(s)

• do not use within 1 hour after taking an antacid or milk

• you may have stomach discomfort, faintness or cramps



Section 50569-3 (50569-3)

Ask a doctor before use if you have

• stomach pain, nausea or vomiting

• a sudden change in bowel habits that lasts more than 2 weeks

Section 50570-1 (50570-1)

Do not use if you cannot swallow without chewing

Section 51727-6 (51727-6)

Inactive ingredients acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, gelatin, iron oxide, iron oxide black, iron oxide yellow (iron oxide ochre), magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Comments & Questions? 800-824-1706

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Stimulant laxative

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Bisacodyl 5 mg

Section 60561-8 (60561-8)

Other Information

each tablet contains: magnesium 5 mg

• store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)

• use by expiration date on package

• protect from excessive humidity




Advanced Ingredient Data


Raw Label Data

All Sections (JSON)